european biotechnology biotechnology | spring edition | vol. 14 2015 special 63 protect yourself...

Spring 2015

SPECIAL

European Biotechnology

Intellectual Property

61_EBM_1_2015_Special-Title.indd 27 26.02.2015 12:38:15 Uhr

“In the field of Intellectual Property, Boehmert & Boehmert is one of

the leading law firms in Germany.”“kanzleien in deutschl and”

patent lawtrademark lawcopyright lawunfair competition lawpress law and personal rightscampaign advice

patent attorneysbiotechnology:prof. dr. heinz goddardr. jan. b. krausdr. markus engelharddr. thomas bittnerdr. ute kilgerdr. volker scholz

munich bremen berlin duesseldorf frankfurt bielefeld potsdam kiel alicante paris shanghai

Meinekestrasse 26, d-10719 Berlin, telephone +49 (30) 23 60 76 70, telefax +49 (30) 23 60 76 721

Pettenkoferstrasse 20 – 22, d-80336 Munich, telephone +49 (89) 55 96 80, telefax +49 (89) 34 70 10

[email protected], www.boehmert.de

62_EBM_1_2015_Boehmert.indd 1 24.02.2015 17:57:08 Uhr

63European Biotechnology | Spring Edition | Vol. 14 | 2015 SpEcial

Protect yourself against bootleggersIP The emerging biosimilar market is subject to a hefty lawsuit. In March, a preliminary decision over Amgen's and Sandoz' litigation on the Swiss’ biosimilar version of Neupogen is expected, with potential impact on the market access of biosimilars in general. Other challenges in the IP space af-fecting the biopharmaceutical sector involve the EU‘s new clinical trials policy, second medical use patents and EU antimonopoly and antitrust litigations.

Other current legal challenges af-fecting the biopharma branch involve protection of trade secrets. On p.68, experts from Dentons outline the im-pact of new clinical trails reporting duties set to be established in Europe by 2016. How strategies intended to prolong a product's life-cycle can collide with EU competion law, is described by attor-neys at Boehmert&Boehmert. Finally, experts at TaylorWessing give insight on the difficulties to enforce patents of second medical use and protect pat-ented matter against off-label compe-tition. L

In February, shortly after a FDA pan-el gave the green light for marketing a Neupogen copycat in the US, Am-gen took legal action to delay its mar-ket launch. The injunction request is part of a patent suit Amgen filed last November (Case3:14-cv-04741-EDL), in which the US biotech giant accus-es Sandoz of “having not followed all the statutory requirements that must be met before … [Sandoz'] product can legally be sold.” Amgen claims Sandoz deliberately withheld documents until after the deadline – such as its applica-tion for FDA approval – according to the Biologics Price Competition and Inno-

vation Act. The Act requires biosimilar makers to share information on the ap-plication and manufacturing process to give them a chance to see if there are any patent infringements.

Delaying market access for competitors

Amgen wants the court to specify that Sandoz was unable to notify Amgen about its intent to market its Neupogen biosim-ilar until the copycat drug had been ap-proved by the FDA. If the court agrees, this would delay future market launches of every biosimilar approved in the US.

Address: C/O In Conference Ltd, Unit 1, Q Court, Quality Street, Edinburgh EH4 5BPTEL: +44 (0) 131 339 9235 • Email: [email protected]

9th European Conference on Marine Natural Products









www.ecmnp2015.com


30th August to 2nd september 2015The University of Strathclyde

Glasgow, SCOTLAND

9TH EUROPEAN CONFERENCE ON MARINE NATURAL PRODUCTS

30TH AUGUST TO 2ND SEPTEMBER 2015THE UNIVERSITY OF STRATHCLYDEGLASGOW, SCOTLANDWWW.ECMNP2015.COM

+ FREE-

OF-CHARGE

pre-conference

workshop for young

academics

63_EBM_1_2015_IP_intro_tg.indd 63 25.02.2015 18:45:25 Uhr

64 European Biotechnology | Spring Edition | Vol. 14 | 2015SpEcial

Pict

ures

: RGt

imel

ine /

foto

lia 2

015

IP, monopoly & antitrust issues in the pharma sectorPatents Antitrust pitfalls – even the severability clause cannot rescue contracts containing serious antitrust issues that threaten contract and business and may ensue drastic fines.

› Ute Kilger and Julian Waiblinger, Boehmert & Boehmert, Berlin

marketing. Basic patents covering said compounds are often filed at least ten years before market entry. As the pat-ent term is twenty years, basic patents may expire before return-on-invest-ment is reached. Furthermore, valida-tion and development of inventions di-rected e.g. to new medical indications or new administration routes adding substantial value to the patient, also require large investments. Pharma-ceutical companies, therefore, created patent portfolios comprising “second-ary patents” covering the business of said compound to secure later inven-tions. “Secondary patents” may relate to formulations, to new medical uses or to patents covering administration regimens. Such patent portfolios com-prising secondary patents were a focus of the EC when investigating whether pharma life cycle management strat-egies constitute antitrust issues since secondary patents or patent clusters allegedly delay generic market entry. However, patents are granted only for inventions that provide consider-able benefit over the prior art. There-fore, to obtain a patent in case of a medical benefit, shall be justified. In addition, the generic industry is free to use compounds as soon as basic pat-ents expire, but may not use secondary patents directed e.g. to new formula-tions. In countries like India, there is such concern about secondary patents delaying generic market entry that it is quite impossible to obtain patents on

Qualcomm agreed to pay China $975m in fines after a long antitrust inves-tigation into the way the chip-maker licensed patents to Chinese compa-nies in the mobile phone market, and it agreed to relaxed licensing schemes reducing royalty payments that mobile phone makers in China must pay. This issue may also be of concern for phar-maceutical companies.

Monopoly vs Competition Law?

Patents provide monopolies for short periods of time for patentable inno-vations securing return in investment into innovations. Competition law pro-motes or seeks to maintain market competition by regulating anti-com-petitive conduct by companies. Compe-tition law and patent law seem to aim conflicting issues, namely to what ex-tent is it justified to enforce patents to

secure return-on-investment into in-novations and when is a monopoly po-sition abused in conflict with competi-tion law.The European Commission (EC) in-vestigated that question in its competi-tion inquiry in the pharmaceutical sec-tor launched in 2008. The EC’s objective was to examine the reasons why fewer new drugs were brought to market, and why entry of generic drugs was occa-sionally delayed.

Special challenges for the pharmaceutical industry

Pharmaceutical industry faces chal-lenges when seeking return-on-in-vestment for innovations. Pharmaceu-tical products have long product cycles and development is very costly. It may take ten years from inventing pharma-ceutically active compounds to their

64-66_EB1_2015_Special_Kilger_tg.indd 64 26.02.2015 12:39:15 Uhr

We provide strategic counsel from conception to product launch and beyond.

We are recognized year after yearas a top IP firm.

4 reasons to choose Sterne Kessler

We prosecute when the stakes are high. & technically skilled IP professionals.

VISION CONCEPT

VALUESTRATEGY

QUALITY COUNTS ATTORNEYS

TECH SPECIALISTSPA

TENT

AGEN

TS

TOP RANKED FIRM

U.S. NEWS

GOLD STANDARDFOR PATENT

QUALITY

FORTUNE 500GO-TO LAW

FIRM

4

PHDs60+

MIND +MUSCLEin washington, dc and at skgf.com

65_EBM_1_2015_Sterne-Kessler-Goldstein-Fox.indd 1 24.02.2015 17:58:01 Uhr


Pict

ures

: Ber

told

Wer

kman

n / f

otol

ia 2

015

new formulations. It is reasoned that such “inventions” are of minor value and lack substantial benefit to justify a monopoly. Such patents were tricks of the industry used to keep generics off the market. This reasoning is not plau-sible, because if secondary patents di-rected to new formulations are of no value, generic companies may choose non-patented formulations comprising the active ingredient. If, however, new formulations provide a benefit and the generic industry does not want to do without it, these formulations must be eligible for patent protection.

The European Commission’s focus on Patent Settlements

Another issue concerns the EC. Fol-lowing its sector inquiry of 2009, it an-nounced it would intensify its scrutiny of the pharmaceutical sector under EU competition law, including the contin-ued monitoring of settlements between originator and generic drug companies. According to the EC, generic delays are problematic because generic products are cheaper two years after market en-try. Competition by generic products resulted in lower prices for consum-ers. In its sector inquiry, the EC found that originator companies use instru-ments, e.g. patent settlements, to ex-tend the commercial life of their prod-ucts without generic entry.

Patent Settlements vs Competition Law concerns?

Patent settlements are agreements to settle patent disputes. Under EU com-petition law, settlements can be re-garded as a legitimate means to end private disputes or litigation. This is acknowledged by the EC in its 5th Re-port on the Monitoring of Patent Set-tlements of 5 December 2014. It states that settlements may save courts and patent offices time and effort, and could have a positive impact in the society’s best interests. However, some forms of settlements in the pharmaceutical sector may be problematic from a com-

petition law perspective. According to the EC, this holds especially true for settlements leading to delayed gener-ic entry in return for value transfer by the originator to the generic company. Such agreements are also referred to as “Pay-for-Delay”-agreements. Oth-er problematic settlements include agreements on restrictions beyond the territorial scope, the period of protec-tion or the exclusionary scope of the patent. According to the EC, also agree-ments on a patent, which the holder knows does not meet the patentability criteria, can be problematic under EU competition law.

apply for patents, to enforce them, to transfer technologies and to settle liti-gation, but that Servier misused these tools by shutting out a competing tech-nology and buying out competitors that had developed cheaper drugs, to avoid competition on their own merits. The EC held that this violated EU antitrust rules prohibiting the abuse of a domi-nant market position (Article 102 of the Treaty on the Functioning of the Euro-pean Union - “TFEU”). The patent set-tlements between Servier and its ge-neric rivals were also anti-competitive agreements prohibited under Article 101 TFEU.

Conclusion

The above decisions of the EC do not imply that all patent settlements per se violate EU competition law. On the con-trary: the EC’s 5th Report on the Mon-itoring of Patent Settlements of 5 De-cember 2014 suggests that the number of patent settlements giving rise to an-titrust concerns is low. The Commis-sion points out that, generally, phar-maceutical companies settle patent disputes in line with EU antitrust rules. However, as assessments of patent set-tlements for compliance with antitrust rules must be made on a case-to-case basis, it is advisable for originators and generic companies to examine relevant antitrust implications before entering into such settlements.

The risks at stake are considera-bly high: agreements containing pro-visions that are prohibited under EU competition law can be void as a whole. More importantly, the parties to anti-competitive agreements run the risk of being fined with substantial charg-es by the EC or by national competi-tion authorities. Furthermore, there is a substantial risk that companies affected by an anti-competitive agree-ment raise damage claims against the parties of the agreement. Hence, it is key for companies in the pharmaceu-tical industry to assess potential risks under EU competition law before it be-comes too late or too expensive. L

Following the Citalopram case, in which the EC fined the Danish originator com-pany Lundbeck with Q93.8m for en-tering into a “Pay-for-Delay”-agree-ment with generic drug companies, the EC has continued its approach on anti-competitive patent settlements. In 2014, the EC imposed fines total-ling Q427.7m on the French originator company Servier and five producers of generic medicines for concluding a series of agreements aimed at protect-ing Servier’s bestselling drug, Perindo-pril, from price competition by generic companies. The EC found that, through an acquisition of technology and a se-ries of patent settlements with gener-ic competitors, Servier implemented a strategy excluding competitors and delaying entry of generic drugs to the detriment of the public and in breach of EU antitrust rules. The EC pointed out that it was legitimate and desirable to

64-66_EB1_2015_Special_Kilger_tg.indd 66 26.02.2015 12:39:31 Uhr

Challenging the status quo.Dentons. The Global Elite law firm created by Salans, FMC and SNR Denton.*We support your success in the Life Sciences Sector. We offer comprehensive industry-specific advice, from M&A transactions, licensing and regulatory issues to financing deals.

Peter Homberg, PartnerFrankfurtT +49 69 45 00 12 [email protected]

dentons.com

© 2015 Dentons. Dentons is a global legal practice providing client services worldwide through its member firms and affiliates. Please see dentons.com for Legal Notices.

*Acritas Global Elite Law Firm Brand Index 2013 and 2014.

Jean-Marc Grosperrin, PartnerParisT +33 1 42 68 92 [email protected]

27673-European Biotechnology News Advert_v1.indd 1 18/02/2015 12:1067_EBM_1_2015_Dentons.indd 1 24.02.2015 17:59:00 Uhr


Pict

ures

: Afr

ica S

tudi

o - F

otol

ia.c

om

Transparency vs protection of business secrets EU clinical Trials rEgUlaTion Balancing confidientiality vs transparency is the goal of new EU rules.

› Peter Homberg, Partner, Dentons, Frankfurt/Main, Germany; Jean-Marc Grosperrin, Partner, Dentons, Paris, France

has been completed, or the applicant for marketing authorisation has withdrawn the application.According to the Regulation, the EU database shall be publicly accessible un-less, for all or part of the data and infor-mation contained therein, confidentiality is justified due to (i) protecting personal data in accordance with Regulation (EC) No 45/2001, (ii) protecting commercial-ly confidential information, in particular through taking into account the status of the marketing authorisation for the me-dicinal product, unless there is an over-riding public interest in disclosure, (iii) protecting confidential communication between Member States in relation to the preparation of the assessment re-port or (iv) ensuring effective supervision of the conduct of a clinical trial by Mem-ber States. No personal data of subjects shall be publicly accessible.

Summary and Outlook

Despite the fact that clinical trials are a strong economic factor in the EU, it seems that the European Parliament and the Council have decided to give ab-solute priority to the protection of public health and thus enhancing transparency to the disadvantage of the protection of the business secrets of sponsors. There-fore, sponsors should consider that their business secrets will not be sufficiently protected under the Regulation. This in turn carries the risk that Europe will be-come less attractive for clinical trials. L

Clinical trials are a significant econom-ic factor with an investment volume of around Q20bn per year in the European Union (EU). They are a necessary precon-dition in the process of obtaining a mar-keting authorisation for medicinal prod-ucts. Furthermore, the effects of one or more new or already approved drugs are established, compared, and tested with-in the scope of clinical trials with medic-inal products for human use, in order to develop and enhance medicinal products and methods. This also leads to benefits for patients who can gain access to in-novative treatments as a result of such clinical trials.

Regulatory Framework and objective of the Regulation

Currently, the main regulatory frame-work regarding clinical trials in Europe is stipulated in the Directive 2001/20/EC. On 27 May 2014, the Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“Regulation”) was published in the Offi-cial Journal of the European Union and entered into force on 6 May 2014. How-ever, the regulation will apply no earlier than 28 May 2016. According to recital (85) of the Regulation, its objective is “to ensure that, throughout the Union, clini-cal trial data are reliable and robust while ensuring respect for the rights, safety, dignity and well-being of subjects”.

Transparency and Confidentiality

The Regulation contains, inter alia, stip-ulations regarding a new EU portal and EU database in which the clinical trial re-sults must be made available to the pub-lic. This obligation applies to all clinical trial results, regardless of whether the outcome of the trial was positive or neg-ative or even if the clinical trial had been withdrawn. Therefore, a summary of the clinical trial results must be made avail-able to an EU database one year from the date of their completion. This summa-ry shall be accompanied by a summary written in a manner that is understand-able to laypersons. Model contents are set out in the attachment of the Regula-tion for both types of summaries. In cas-es where the clinical trial is intended to be used for obtaining a market authori-sation for the investigational medicinal product, the applicant is also required to submit the clinical trial report with-in thirty days after the market authori-sation has been granted, the procedure for granting the marketing authorisation

68_EB_1_2015_Special_Peter_tg.indd 68 26.02.2015 12:40:26 Uhr

> Life Sciences & Healthcare

> Life Sciences – Transactions

> Europe > Middle East > Asia www.taylorwessing.com

© Taylor Wessing 2014

Taylor Wessing has been recognised among the leading inter-national law firms in the life sciences and healthcare sectors. For more than 30 years, we have advised healthcare service providers, statutory health insurance funds as well as pharma-ceutical, medical devices and biotech companies and have thus acquired a profound knowledge of the industry.

Our Life Sciences & Healthcare industry group is composed of an international team of around 60 specialists in various legal disciplines, about 20 of them in Germany. One focus of the group‘s consultancy is the preparation and support of transactions. Legal experts from the corporate, IP, commercial, antitrust and pharmaceutical practice areas have combined their longstanding experience and comprehensive know-how to ensure the success of transactions of all kinds.

Your contact partner:Dr. Manja Epping, Partner IP/Pharma and Head Life Sciences Germany e-mail: [email protected]

Life Sciences & Healthcare

Our services for Life Sciences Transactions:

> International Partnering Projects

> Patent and Know-How Licenses

> Research & Development Cooperations

> M&A-Transactions incl. Corporate Finance

> Private Equity and Venture Capital

> Strategical IP Advice and Due Diligence

69_EBM_1_2015_Taylor-Wessing.indd 1 24.02.2015 18:00:22 Uhr


Pict

ures

: iSt

ockp

hoto

Infringement of second medical use patents IP Enforcement of second medical use patents is difficult, particularly in the European lead market Germany. Due diligent fact finding and presentation of evidence are crucial for success.

› Dr. Anja Lunze, LL.M. Attorney at Law, Partner, TaylorWessing, Munich

used for the use of the invention. There is no case law on this specific ques-tion in Germany yet, on whether and to what extent only indications for a po-tential cross-label use such as a high-er number of sales can create the nec-essary subjective link, bearing in mind that the manufacture of the medica-ment as such is in the public domain and allowed.In a similar way as the UK, Arnold J very recently found that if there is no evi-dence that the generic manufacturer in-tended the drug to be used for the pat-ented use, there is no infringement[4]. In summary, it is difficult, but not im-possible to enforce second medical use patents. The chances strongly depend from diligent fact finding and presenta-tion of evidence for proving the subjec-tive link between the marketing of the product on the one side, and the inten-tion for its patented use on the other. L

Footnotes

[1] “Off-label” use usually means the use of a drug for an

unapproved indication, age group, dosage or way of administration while “cross-label” use means the use of a drug for an approved and patented indication, age group, dosage or way of administration that is not mentioned on the label instructions. In this regard, the often used term “skinny labelling” refers to label instructions that do not mention the patented use, but only the uses that are already off-patent.

[2] Düsseldorf District Court, docket number 4a 0 12/03, 24 February 2004, GRUR-RR 2004, 193 – Ribavirin; Düsseldorf Court of Appeal, docket number 2 U 54/11, 31 January 2013 – Cistus Incanus; Düsseldorf District Court, docket number 4a O 145/12, 14 March 2013 – Chronic Hepatitis C.

[3] Düsseldorf Court of Appeal, Cistus Incanus, ibid; Düs-seldorf District Court, Chronic Hepatitis C, ibid.

[4] Warner-Lambert Company LLC v Actavis Group PTC EHF & Ors, [2015] EWHC 72 (Pat).

Finding a new therapeutic indication for a known chemical compound and ad-justing known compounds in new dos-age regimes or to a specific group of pa-tients, is an important area of innovation in pharmaceutical research. While it is well established that patent protection can be granted for such second medical use, the practical enforcement of second medical use patents, in particular with regard to adducing evidence, and in cas-es of cross label and off-label use[1], is rather difficult in practice. Second medical use patents are only infringed if the drug as marketed is manifestly arranged (or obviously pre-pared) for the use claimed in the pat-ent[2]. Such manifest arrangement is given if the instructions on the label or package leaflet refer to the patented use or if ready-to-use preparations of the drug are provided.

Challenge skinny labelling…

More complicated in practice are cas-es of cross-label or off-label use where the drug is marketed without the indi-cation to the patented use (“skinny la-belling”), but where the drug is pre-scribed or used for a patented purpose. Two recent German cases found that in-formation about the drug in marketing materials and flyers, as well as expla-nations made by sales people, are not sufficiently attributable to the product[3]. Even though the sales people explain-ing that the product could also be used

for the patented purpose were employ-ees of the drug manufacturer, the courts denied direct infringement of the drug manufacturer. The courts argued that the drug had been marketed as such – in a way not covered by the second med-ical use patent. As the flyers, marketing materials and explanations were not di-rectly linked to the product, it is not cer-tain that the customer would have tak-en them into consideration at all. So it is not clear that the patented purpose of the second medical use patent would have been fulfilled.

… and cross-label use

In cases of cross-label use, it may be asked whether the manufacturer could have known, or it won't have been ob-vious from the circumstances, that the drug was suitable and intended to be

70_EB_1_2015_Special_Manja_tg.indd 70 26.02.2015 12:40:49 Uhr

european biotechnology biotechnology | spring edition | vol. 14 2015 special 63 protect yourself...

Documents